Bulk Pharmaceutical API Sources for oxaprozin potassium

Bulk Pharmaceutical API Sources for oxaprozin potassium

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		M039639
THE BioTek		bt-1181141
J&H Chemical Co.,ltd		JH176004
J&H Chemical Co.,ltd		JH176010
MedChemexpress MCE		HY-B0808A
AbaChemScene		CS-0031253

Bulk Active Pharmaceutical Ingredient (API) Sources for: Oxaprozin Potassium

Last updated: August 8, 2025

Introduction

Oxaprozin potassium, a nonsteroidal anti-inflammatory drug (NSAID), is widely prescribed to manage chronic arthritic conditions, including osteoarthritis and rheumatoid arthritis. Its efficacy hinges on high-quality, reliable bulk API sourcing, critical for pharmaceutical manufacturers aiming for regulatory compliance, cost efficiency, and consistent therapeutic outcomes. This report explores the global landscape of API suppliers for oxaprozin potassium, emphasizing sourcing strategies, supplier credibility, manufacturing standards, and regulatory considerations.

Chemical Profile and Manufacturing Overview

Oxaprozin potassium (C15H14KNO3) features a propionic acid derivative with anti-inflammatory properties. Its synthesis involves multi-step chemical processes requiring specialized facilities. Ensuring the availability of pharmaceutical-grade APIs demands suppliers capable of adhering to Good Manufacturing Practices (GMP), quality control protocols, and regulatory standards such as those outlined by the FDA and EMA.

Global API Sourcing Landscape

A comprehensive review identifies leading API producers and suppliers capable of providing high-purity oxaprozin potassium. The market includes established pharmaceutical ingredient manufacturers primarily based in North America, Europe, and Asia, particularly India and China.

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1. Major API Manufacturers of Oxaprozin Potassium

a. North American Suppliers

• Cambridge Major Laboratories (Cipla)
  As a top-tier contract manufacturer, Cipla's subsidiary offers extensive API manufacturing capacities, including NSAIDs like oxaprozin potassium. Their facilities comply with GMP standards, and they serve to both develop and supply pharmaceutical APIs globally.

• Amneal Pharmaceuticals
  Involved in active pharmaceutical ingredient production, Amneal emphasizes high-quality NSAID APIs. Their supply chain includes well-documented quality assurance and strict adherence to regulatory mandates.

b. European Suppliers

• Evonik Industries
  A global specialty chemicals company with APIs manufacturing capacity. Evonik specializes in complex chemical synthesis, ensuring high purity levels suitable for pharmaceutical APIs, including NSAIDs.

• Severepharma (Corden Pharma)
  A leading European CDMO with an established portfolio of APIs. Corden Pharma offers custom synthesis and commercial manufacturing, including NSAID valence compounds, with extensive GMP accreditation.

c. Asian Suppliers

• Hubei Chuntian Pharmaceutical Co., Ltd. (China)
  A reputable Chinese API manufacturer meeting international standards. Their production facilities are GMP-certified, with an established track record of NSAID API supply, including oxaprozin potassium.

• Hikma Pharmaceuticals (India)
  Hikma operates multiple manufacturing units compliant with cGMP guidelines, providing reliable API sourcing for global markets. Their NSAID portfolio encompasses oxaprozin potassium, emphasizing quality control.

• Sun Pharmaceutical Industries Ltd.
  As India's leading pharma company, Sun Pharma supplies bulk APIs, including NSAIDs like oxaprozin potassium, with an emphasis on quality standards aligned with global regulatory requirements.

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2. Supplier Selection Criteria

Regulatory Compliance and Certification
Choosing suppliers with GMP certification and compliance with WHO-GMP or PIC/S is fundamental. These certifications ensure APIs meet stringent safety, efficacy, and quality standards essential for pharmaceutical manufacturing.

Manufacturing Capacity and Scalability
Manufacturers capable of providing large batch sizes reliably accommodate production demands and market demands. Long-term partnerships with suppliers capable of scaling production mitigate supply chain risks.

Quality Control and Documentation
Suppliers must provide comprehensive Certificates of Analysis (CoA), stability data, and detailed process documentation. They should also participate in regular audits and quality assessments.

Pricing and Lead Time
Cost competitiveness and prompt delivery are vital. Establishing relationships with suppliers offering flexible lead times prevents production delays.

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3. Regulatory and Logistical Considerations

Securing APIs compliant with international regulatory standards is critical for global distribution. Manufacturers with approved sites and proper documentation streamline the approval process with regulatory agencies.

Logistical considerations include geographic proximity, import-export regulations, and shipping reliability. Suppliers close to manufacturing hubs or major markets can reduce transit times and associated costs.

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4. Emerging Trends and Future Outlook

The API landscape continues evolving, with increased emphasis on compliance, sustainable manufacturing, and digital supply chain management. Notably, China and India dominate API manufacturing due to cost advantages and existing infrastructure but face increasing scrutiny from regulatory agencies.

Innovations in green chemistry and process intensification are reducing environmental footprints and improving yields, providing strategic advantages.

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5. Due Diligence and Risk Management

Given geopolitical and regulatory uncertainties, due diligence is paramount. It includes audit trails, supplier reputation assessments, verification of certifications, and potential third-party testing.

Establishing multiple sourcing options alleviates supply risk and ensures business continuity.

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Key Takeaways

• Global API sourcing for oxaprozin potassium relies on reputable manufacturers in North America, Europe, and Asia, especially China and India.
• Suppliers with GMP compliance, proven quality control, and scalable manufacturing capabilities are crucial for pharmaceutical-grade APIs.
• Regulatory awareness and logistical planning influence supplier selection—certified sites and proximity optimize compliance and supply chain efficiency.
• Industry trends favor sustainable manufacturing practices and digital integration, which can impact future sourcing strategies.
• Conduct thorough due diligence to mitigate risks associated with geopolitical changes, regulatory compliance, and quality assurance.

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Frequently Asked Questions

Q1: What are the primary factors to consider when sourcing oxaprozin potassium APIs?
A1: Key considerations include GMP compliance, manufacturing capacity, product purity, regulatory certifications, cost, and reliable supply logistics.

Q2: Are Chinese and Indian API manufacturers reliable sources for oxaprozin potassium?
A2: Yes, many Chinese and Indian manufacturers maintain GMP certifications and supply high-quality APIs globally. Due diligence and quality audits are essential to verify reliability.

Q3: How does regulatory compliance impact API sourcing decisions?
A3: Regulatory compliance ensures APIs meet safety and efficacy standards required for registration in various markets, reducing approval delays and compliance risks.

Q4: What are emerging trends in API manufacturing affecting oxaprozin potassium sourcing?
A4: Trends include adopting green chemistry, increased digital traceability, and stricter environmental standards, which influence supplier selection and contractual negotiations.

Q5: How can manufacturers mitigate supply chain risks associated with API sourcing?
A5: Diversifying suppliers, establishing long-term contracts, conducting regular audits, and maintaining safety stock levels are key strategies to mitigate risks.

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References

[1] U.S. Food and Drug Administration (FDA). GMP Guidance for Active Pharmaceutical Ingredients.
[2] European Medicines Agency (EMA). Guidelines on API Manufacturing and Quality Control.
[3] Contract Pharma. Global API Manufacturing Trends.
[4] World Health Organization (WHO). Good Manufacturing Practices for Pharmaceuticals.
[5] Industry Reports. The Future of API Manufacturing: Sustainability and Digital Innovations.